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Comparison of the Efficacy and Safety of Ivermectin to Permethrin

This study has been completed.
Sponsor:
Information provided by:
University Ghent
ClinicalTrials.gov Identifier:
NCT00262418
First received: December 4, 2005
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

Comparison of the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies


Condition Intervention Phase
Scabies
 Drug: Administration of ivermectin or permethrin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Double Dummy Study to Compare the Efficacy and Safety of a Single Administration of Ivermectin to a Single Administration of Permethrin for the Treatment of Scabies

Resource links provided by NLM:

MedlinePlus related topics: Scabies
U.S. FDA Resources

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Clinical healing of the skin injuries [ Time Frame: on day28 ]

Secondary Outcome Measures:
  • Decrease of itching [ Time Frame: on day28 ]
  • Amelioration of the life quality [ Time Frame: on day28 ]
  • Number and gravity of adverse events

Enrollment: 160
Study Start Date: July 2004
Study Completion Date: May 2005
Detailed Description:

Administration of ivermectin or permethrin on day0 Clinical examination and pictures on day0, day14 and day28 Blood sample on day0 VAS for pruritus, DLQI and SF-36 on day0, day14 and day28

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

At least one of the following inclusion criteria:

  • Scabies tunnels
  • Positive microscopic examination (acarids, faeces or ova)

At least two of the three following inclusion criteria:

  • Non-specific injuries with a typical distribution pattern
  • Serious itching which increases during the night
  • Family or contacts with similar complaints

Exclusion Criteria:

  • Treatment for scabies < 4 weeks ago
  • Treatment with corticoids < 1 week ago
  • Pregnancy
  • Breast-feeding
  • HIV
  • Serious immunodepressive patients
  • Sensitivity or allergy to one of the components of the study medication
  • Damage of the central nerve system
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262418

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Investigators
Principal Investigator: Jean-Marie Naeyaert, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00262418     History of Changes
Other Study ID Numbers: 2004/212
Study First Received: December 4, 2005
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Ivermectin
 Permethrin
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013